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The Vertical Group
Investing for Innovation

New Machine Designed To Streamline Dialysis

6/29/2016

 
Via: ABC7 News
Millions of kidney patients face the same unchanging ritual, four hours a day, three days a week hooked to a dialysis machine. A Bay Area startup believes it can streamline that experience.

They started rolling out a new dialysis machine known as the Tablo, designed to work something like a smart phone app, according to Leslie Trigg, CEO of Outset Medical in San Jose.

"So we first took a look at what dialysis machines look like today and then thought, how could we re-imagine it if we were a Google, or an Apple," says Trigg.

The answer centers on a touch screen interface, which they say allows patients to set up the dialysis session themselves in about 10 minutes. The interface includes an audio test to make sure patients can hear any alarms. It then runs through a checklist to make sure they have all the supplies they need for dialysis.

Read More: http://abc7news.com/health/new-machine-designed-to-streamline-dialysis/1408926/

World Economic Forum Group Honors Omada Health for Medical Innovation 

6/28/2016

 
Via: The American Journal of Managed Care 
World Economic Forum’s Technology Pioneers has announced its 2016 honorees for advances in the design, development and deployment of new technologies and innovations, including 22 US companies.  Of the various health, environment and energy companies awarded the honor, Omada Health was recognized for its work in helping to combat the public health challenge of chronic disease.  

The San Francisco-based company is a digital behavioral medicine organization that works with employers, health plans and health systems to digitally administer intensive behavioral counseling for individuals with elevated risk for chronic diseases, such as type 1 and type 2 diabetes as well as heart disease. Omada Health functions on a pay-for-outcomes model and strives to align its own incentives with those of their partners and members.  

​ “Being recognized as a technology pioneer by the World Economic Forum is an acknowledgement that Omada’s approach to tackling the epidemic of chronic disease has the potential to address a generational public health challenge,” Sean Duffy, Omada Health CEO and co-founder, said in a statement. “Digital behavioral medicine can scale and deliver effective interventions to millions of people who need them the most. In a world where chronic disease now kills more people than infectious disease, the World Economic Forum’s award gives Omada a continued mandate to reach as many at-risk individuals as possible.”


Read More: http://www.ajmc.com/newsroom/world-economic-forum-group-honors-omada-health-for-medical-innovation#sthash.xr6urJcW.dpuf

Omada Health Awarded as Technology Pioneer by World Economic Forum

6/26/2016

 
Via: Omada Health
San Francisco, CA (June 27, 2016) – Omada Health, the San Francisco-based digital behavioral medicine company, was today awarded as one of the World Economic Forum’s Technology Pioneers, a selection of the world’s most innovative companies. Omada works with employers, health plans, and health systems to digitally administer intensive behavioral counseling to individuals at elevated risk of chronic conditions like type 2 diabetes and heart disease. The company generates its revenue on a pay-for-outcomes model that aligns its incentives with its organizational partners and individual participants.  

Omada Health was chosen by a professional jury among hundreds of candidates as one of the 30 selected companies. Thanks to its selection, it will have access to an influential and sought-after business and political network worldwide. Sean Duffy, the Co-Founder and Chief Executive Officer, is participating in the Annual Meeting of the New Champions, and many Technology Pioneers will also participate in the World Economic Forum Annual Meeting 2017 in Davos-Klosters, Switzerland. 

Read More: https://www.omadahealth.com/news/omada-health-awarded-as-technology-pioneer-by-world-economic-forum

The Challenge Of Taking Health Apps Beyond The Well-Heeled

6/22/2016

 
Via: NPR
​"...In California and Washington state, San Francisco-based Omada Health is testing a version of Prevent, a diabetes and heart disease prevention program that's been modified for "underserved" populations – basically people on Medicaid or who are uninsured. The free program offers patients a digital scale as well as behavior counseling and education, access to a personal health coach and an online peer network.

​
To adapt the program, the company made it available in Spanish and English and lowered its reading level from ninth grade to fifth grade. Bilingual health coaches were hired, and the educational materials now acknowledge potential food access, neighborhood safety and economic issues that participants may face, said Eliza Gibson, Omada's director of Medicaid and safety-net commercial development.

The scale doesn't require a wireless connection, and the patient just needs to be able to access the Internet for one hour each week, Gibson said.

Omada is enrolling 300 community clinic patients in Southern California and rural Washington in a year-long clinical trial of Prevent, in hopes that the program can demonstrably slow the progress of diabetes."

Read More:
 http://www.npr.org/sections/health-shots/2016/06/23/483098999/the-challenge-of-taking-health-apps-beyond-the-well-heeled

27 Innovative Medtech Products Recognized as Winners at the 2016 Medical Design Excellence Awards

6/14/2016

 
Via: PR Newswire
The MDEAs took place June 14, in conjunction with MD&M East, happening this week in New York City
NEW YORK, June 15, 2016 /PRNewswire/ -- The Medical Design Excellence Awards (MDEA), recognizing the technological achievements of medical device manufacturers, announced the 2016 winners at a special ceremony on the evening of June 14. Produced by Medical Device and Diagnostic Industry (MD+DI), the awards ceremony honored innovation across nine categories, announcing gold, silver and bronze medal winners in each category, plus naming the best in show and revealing the readers' choice winner. The 2016 MDEA ceremony was held in conjunction with Medical Design & Manufacturing (MD&M) East, which is taking place this week at the Jacob K. Javits Convention Center in New York, NY.
...
"MD+DI and MD&M East are excited to honor the MDEA winners for excellence in medical product design and engineering," saidJamie Hartford, editor-in-chief of MD+DI and director of medical content for the Advanced Manufacturing Group of UBM Americas. "These products will improve the lives of patients and individuals, and we can't wait to witness their full potential."

​The 2016 MDEA Winners are as follows:


General Hospital Devices and Therapeutic Products
Gold: Equashield—Equashield Medical Ltd. 
Silver: Outset Tablo—Outset Medical 
Bronze: CoSense—Capnia

Read More: ​http://www.prnewswire.com/news-releases/27-innovative-medtech-products-recognized-as-winners-at-the-2016-medical-design-excellence-awards-300284816.html

Silk Road Medical Announces Updated Clinical Data on TCAR Presented at the 2016 Society for Vascular Surgery Annual Meeting

6/14/2016

 
Via: PR Newsire
Presentations from the ROADSTER Study Highlight the Continued Safety, Efficacy and Durability of TransCarotid Artery Revascularization
SUNNYVALE, Calif., June 15, 2016 /PRNewswire/ -- Silk Road Medical, Inc., a company dedicated to preventing the devastating burden of stroke through surgical innovation, announced that the 2016 Vascular Annual Meeting of the Society for Vascular Surgery (SVS) held June 8-11 in National Harbor, MD featured six presentations on the company's ENROUTE® Transcarotid Neuroprotection and Stent System, the first and only products specifically designed and indicated for TransCarotid Artery Revascularization (TCAR).
​

Christopher Kwolek, MD, Director of the Vascular and Endovascular training program at Massachusetts General Hospital, Chief of Vascular Surgery at Newton Wellesley Hospital, and National Co-Principal Investigator for the ROADSTER Trial, presented "TransCarotid Artery Revascularization with High-Rate Flow Reversal Embolic Protection Demonstrates Improved Stroke and Death Rate Following FDA Premarket Clearance."  Dr. Kwolek presented a 30 day all stroke rate of 1.3% from the Continued Access cohort of patients from the ROADSTER trial, which consisted of an additional 78 high surgical risk patients enrolled beyond the Pivotal cohort of 141 patients while the Pre Market Clearance Application was under review by the Food & Drug Administration (FDA). This compares to a 30 day all stroke rate of 1.4% in the Pivotal cohort, for a combined rate of 1.4% in 219 patients.  The 30 day stroke and death rates were 2.8%, 1.3% and 2.3% in the Pivotal, Continued Access, and combined cohorts, respectively.  Dr. Kwolek commented that "the combined outcomes in high surgical risk patients are remarkably better than high surgical risk patients treated with conventional carotid endarterectomy (CEA)."

Read More: ​http://www.prnewswire.com/news-releases/silk-road-medical-announces-updated-clinical-data-on-tcar-presented-at-the-2016-society-for-vascular-surgery-annual-meeting-300284764.html


Shire Receives FDA Breakthrough Therapy Designation for SHP621 and SHP625, Investigational Products for Rare Gastrointestinal Conditions

6/13/2016

 
Via: Shire
Update on Meritage Program:
​

Lexington, Mass. – June 13, 2016 – Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for two investigational products for rare diseases: SHP621 (budesonide oral suspension, or BOS) for eosinophilic esophagitis (EoE), and SHP625 (maralixibat) for progressive familial intrahepatic cholestasis type 2 (PFIC2).
​
“Receiving Breakthrough Therapy Designation on two pipeline products this past week reflects the potential of our strong and innovative pipeline of more than 60 programs,” said Flemming Ornskov, M.D., MPH, and CEO, Shire. “Shire is committed to bringing innovation to the rare and specialty areas we focus on. We persevere to see compounds through the many stages of development through their challenges and successes, and always keep patients with unmet needs top of mind.”

Read More: https://www.shire.com/newsroom/2016/june/13-06-2016-shire-receives-fda-breakthrough-therapy-designation

Outset Medical featured in New England Journal of Medicine Catalyst Article

6/9/2016

 
Via: NEJM Catalyst 
"....Outset Medical, based in San Jose, California, seeks to empower dialysis patients through technology.

Outset’s Tablo device aims to transform dialysis in the way ATMs have done for banking and self-checkout kiosks for grocery shopping.

The Tablo, which resembles a dormitory refrigerator, breaks down the act of dialyzing in simple steps. Patients and/or technicians are given prompts on a video screen. Concentrates required for the session come in modules easily installed into the machine, which in turn can be connected to a sink faucet, bypassing the need to purify the water supply. There is also no need for 'stringing' — the need to push tubing throughout the device much in the same way an old film projector is threaded. Patients can hook themselves up in about 10 minutes and as quickly as six minutes, according to Outset CEO Leslie Trigg."

Read More: http://catalyst.nejm.org/the-big-business-of-dialysis-care/

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